Urinary incontinence in women is a common and potentially a serious social problem. Most often, the incontinence is of the stress type, i.e., it occurs when intra-abdominal pressure is suddenly raised as during coughing, sneezing, laughing and physical exercise. Sometimes the problem will only occur occasionally when intra-abdominal pressure is raised excessively. In other cases, a minimally exerted stress will cause leakage, particularly in the erect position. Repeated leakage may cause skin irritation and be an embarrassment to the patient, especially when it is noticeable as an offensive odor.
One solution to the problem of urinary incontinence is the use of absorbent pads in the genital region. However, these pads are unacceptable due to the limited volume of urine they can absorb, the associated odor, and the high probability that skin infection and inflammation will follow.
It has been proposed that urinary incontinence can be regulated by altering the angular relationship between the urethra and bladder. That is, it has been observed that by making the urethrovesical angle, i.e., the angle between the urethra and the bladder base, more acute, urinary incontinence can often be reduced. U.S. Pat. No. 3,705,575 to Edwards is based on this principle. It discloses an incontinence device that changes the urethrovesical angle. The device includes a first member which is adapted to fit within the vagina and which applies pressure to the urethra and a second member adapted to bear against the external pubic area of the female body. However, this device is uncomfortable to wear and may cause irritation to the vaginal mucosa. Furthermore, the device is not likely to stay in place when inserted into the vagina just inside the introitus and is not inflatable, and therefore, can not be expanded to give just the right amount of support.
Another incontinence device is that disclosed in U.S. Pat. No. 3,554,184 to Habib. The incontinence device is formed from silicon rubber and designed to be inserted into the external region of the vagina. The patient must wear a belt, coupled to the member, whereby the latter is thrust against the anterior wall of the vagina with a sufficient magnitude to efficiently block the flow of urine through the urethra. However, besides involving the wearing of an uncomfortable belt, the device is only partially contained within the vagina and may therefore cause irritation of the labia.
Bonner in U.S. Pat. No. 3,646,929 discloses a female incontinence device which comprises a generally flat support adapted for insertion into the vagina. A flexible diaphragm is coupled to the support and is inflated to expand in an upward direction against the anterior wall of the vagina for applying pressure thereupon to block the urethra. However, this device blocks all flow of urine from the bladder. Therefore, when a patient needs to urinate the device must be deflated and then inflated after micturition.
Corey in U.S. Pat. No. 4,139,006 discloses a device completely inserted into the vagina for displacing a surface of the anterior wall of the vagina, and an intermediate section of the urethra adjacent thereto, toward the pubic bone, thereby reducing the urethrovesical angle for restoring the patient's natural control of the flow of urine through the urethra from the bladder to the urethral opening. However this device is not likely to stay in place when inserted into the vagina only just inside the introitus, is not inflatable and, therefore, can not be expanded to give just the right amount of support.
Surgery offers another solution to the problem. Almost all surgical procedures improve support to the upper urethra which is thereby better exposed to changes in intra-abdominal pressure. When pressure is raised in the abdomen by a stress condition such as coughing, the increased pressure will be transmitted after the operation, not only to the bladder, but also to the same, or almost the same, extent to the upper urethra. Thus, a higher pressure in the upper urethra than in the bladder will be maintained regardless of pressure changes in the abdomen. Digital support on each side of the upper urethra, Bonney's maneuver, has often been tried by the physician examining prior to surgery. If such support inhibits incontinence caused by coughing it has been felt that the patient would be a good candidate for surgery. However, surgical procedures are often not to be considered due to the patient's age or medical status. Accordingly, a device for controlling urinary incontinence which overcomes the problems associated with the prior art devices disclosed herein, and which can be used temporarily until an operation can be carried out, or permanently if the patient is a poor operative risk, would be desirable. The device should permanently offer the same support as the examining physician's fingers are offering when Bonney's maneuver is carried out.